Evidence map›Paper›PMID 33518587›Full record

ArticleAnalytical sciences : the international journal of the Japan Society for Analytical Chemistry2021

In-situ Reverse Phased HPLC Analysis of Intact Antibody-Drug Conjugates.

Yutaka Matsuda, Monica Leung, Zhala Tawfiq, Tomohiro Fujii, Brian A Mendelsohn

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Article in Analytical sciences : the international journal of the Japan Society for Analytical Chemistry, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Review
  6. Current advances in separation chemistry for antibody purification and analysis.Analytical sciences : the international journal of the Japan Society for Analytical Chemistry · 2025
    Review
  7. Article
  8. Tag-free protein modification by lipoate ligase A: exploring substrate tolerance.Analytical sciences : the international journal of the Japan Society for Analytical Chemistry · 2024
    Article
  9. Article
  10. Article
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Yutaka MatsudaAjinomoto Co., Inc., 1-1 Suzuki-cho, Kawasaki, Kawasaki, Kanagawa, 210-8681, Japan. yutaka_matsuda@ajinomoto.com.
Monica LeungAjinomoto Bio-Pharma Services, 11040 Roselle Street, San Diego, CA, 92121, United States.
Zhala TawfiqAjinomoto Bio-Pharma Services, 11040 Roselle Street, San Diego, CA, 92121, United States.
Tomohiro FujiiAjinomoto Bio-Pharma Services, 11040 Roselle Street, San Diego, CA, 92121, United States.
Brian A MendelsohnAjinomoto Bio-Pharma Services, 11040 Roselle Street, San Diego, CA, 92121, United States. bmendelsohn@exelixis.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The field of oncology has recently seen an exponential growth in antibody-drug conjugates (ADCs) as a biopharmaceutical class with seven ADCs being launched onto the market in the last ten years. Despite the increase in the industrial research and development of these compounds, their structural complexity and heterogeneity continue to present various challenges regarding their analysis including reaction monitoring. Robust and simple reaction monitoring analysis are in demand in the view of at-line in-process monitoring, and can instill control, confidence and reliability in the ADC manufacturing process. Aiming at providing chromatographic methods for conjugation monitoring, we evaluated herein the potential of utilizing reverse phase HPLC analysis, without sample pretreatment, for characterization of traditional cysteine-based ADCs. This analysis can be used for estimation of drug antibody ratio (DAR), which has shown the same trends and results as other well-established HPLC techniques. This methodology was also applied to three ADCs derived from three different antibodies. Additionally, we analyzed unpurified ADC samples existing in a complex reaction matrix and separated ADC species and payload compounds. This investigation was conducted using three different ADCs based on different payloads. The results described herein indicate the potential application of this RP-HPLC methodology in reaction monitoring studies.

Indexed as

ImmunoconjugatesAntibodiesChromatography, High Pressure LiquidChromatography, Reverse-PhaseReproducibility of ResultsAntibodiesImmunoconjugatesAntibody-drug conjugatecysteine conjugationin process controlin-situ analysisreverse phase HPLC

Identifiers

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.